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Validated Packaging Process - unique in the world


VC999 MEDICAL offers a completely validated packaging process in order to meet the constantly increasing market needs and regulations of the ISO, FDA and MDR without having to make large time and financial investments for packaging qualification and validation.

VC999 MEDICAL has validated a process which includes the machine, the packaging material as well as the validation. This validated process can be directly adopted from you and permit you a flexible medical packaging solution in a cost-effective manner and is fast to implement. All of them is „State of the Art“ with a shelf-life of up to 10 years and for the prevalent materials PA/PE,
Tyvek® and Paper/Film.

We have developed our C6 machine, which covers almost all applications as high lot sizes, long or high goods or nitrogen gassing to minimize your re-qualification costs for more different machines. If necessary the data required for data backup can also be individually transmitted to your own operating system.

Professional cleaning + clean rooms + packaging machines + pre-validated packaging + sterile packaging

We give our customers the security in dealing with the new regulations. We have dealt with the risks involved in certification and we maintain the large network with the many, different contacts. 

  • We have decades of international know-how at our disposal

  • We work just in time and you as a customer save a lot of time and money

  • We take over the customer responsibility

Status in Medtech today

  • Companies work with isolated solutions and many suppliers which means they have to accept long delivery times and extremely cost-intensive warehousing

  • A large part of sterilization today takes place in hospitalst

  • There is no global supplier available for the complete supply chain

  • Immense QM documentations and requalification costs

  • Healthcare associated infections affect about 4% of hospital patients and about 19% of ICU patients and are often associated with significant global morbidity and mortality. It is estimated that this results in an excess healthcare cost worldwide of $9.8 billion.  (Source: EMERGO 2021)

Status in Medtech in the future (MDR / from 2021)

  • The EU has reacted and launched a new, significantly tightened, legislation that will come into force in 2021.

  • Cleaning and packaging are critical components of the product --> the hurdles have been tightened by MDR and the revision of EN ISO 11607ff.

  • The requirement for reprocessing in hospitals has been drastically tightened. Hospitals have to implement them under consideration of product liability. However, hardly any hospital can meet the new requirements --> The switch to sterile (germ-free) products has been initiated.

  • The requirements for non-sterile products have been adapted to the sterile products.

  • The FDA (USA) also follows the MDR in this respect and includes these requirements in its "guidance documents".

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